Rheopheresis Blood Filtration Study for the Treatment of... | NCT00078221

Studies
Rheopheresis Blood Filtration Study for the Treatment of Dry Age-Related Macular Degeneration (AMD)

NCT00078221

Sponsor

OccuLogix

Status

Unknown status

Last Update Posted

May 9, 2008Estimated

Enrollment

180

Phase

Phase 3

Conditions

Macular Degeneration

Interventions

Rheopheresis blood filtration

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 1999

Primary Completion Date

Not provided

Completion Date

Dec 2005

First Submitted Date

Feb 20, 2004

First Submission Date that Met QC Criteria

Feb 27, 2004

First Posted Date

Mar 1, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2008

Last Update Posted Date

May 9, 2008Estimated

Description Module

Brief Summary

AMD is a progressive disease of the retina which is nourished by a network of tiny blood vessels. There is evidence to suggest that the flow of nutrients to the retina is impaired in patients with AMD. Rheopheresis blood filtration uses blood filters that deplete excesses of large proteins, fats and other substances from the blood, improving blood flow to the macula, potentially improving vision.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180

Name	Type	Description	Arm Group Labels	Other Names
Rheopheresis blood filtration	Device

Eligibility Module

Eligibility Criteria

Age 50-85
Diagnosis of Dry AMD
BCVA between 20/32 and 20/125 in at least one eye
Numerous large plaques (soft drusen)
No history of HIV, Hepatitis B or C
Elevation of certain blood factors, such as total cholesterol, fibrinogen, and IgA

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Irving Siegel, MD	OccuLogix	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retina Vitreous Associates		Beverly Hills	California	90211	United States
Aran Eye Associates

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12545682	Background	Pulido JS; Multicenter Investigation of Rheopheresis for AMD (MIRA-1) Study Group. Multicenter prospective, randomized, double-masked, placebo-controlled study of Rheopheresis to treat nonexudative age-related macular degeneration: interim analysis. Trans Am Ophthalmol Soc. 2002;100:85-106; discussion 106-7.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases